TAZORAC- tazarotene gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TAZAROTENE (UNII: 81BDR9Y8PS) (TAZAROTENE - UNII:81BDR9Y8PS)

Available from:

Almirall, LLC

Administration route:

CUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TAZORAC® (tazarotene) Gel, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement. TAZORAC (tazarotene) Gel, 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity. The efficacy of TAZORAC Gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established. The safety of TAZORAC Gel use on more than 20% body surface area has not been established in psoriasis or acne [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. TAZORAC Gel is contraindicated in:  - Pregnancy. Retinoids may cause fetal harm when administered to a pregnant female [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 )]. - Individuals who have known hypersensitivity to any of its components [see Warnings and Precautions ( 5.2 )]. Risk Summary Based on data from animal reproduction studies, ret

Product summary:

TAZORAC (tazarotene) Gel is a translucent, aqueous gel, available in concentrations of 0.05% and 0.1%. It is available in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white propylene screw cap, in 30 g and 100 g sizes. TAZORAC Gel 0.05%        30 g       NDC 16110-833-30 TAZORAC Gel 0.05%        100 g     NDC 16110-833-10 TAZORAC Gel 0.1%          30 g       NDC 16110-042-30 TAZORAC Gel 0.1%          100 g     NDC 16110-042-10 Storage: Store at 20°C to 25°C (68°F to 77°F). Excursions permitted from 15°C to 30°C (59°F to 86°F).

Authorization status:

New Drug Application

Summary of Product characteristics

TAZORAC- TAZAROTENE GEL
ALMIRALL, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TAZORAC GEL SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR TAZORAC GEL.
TAZORAC (TAZAROTENE) GEL, 0.05% AND 0.1%, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
TAZORAC Gel, 0.05% and 0.1% is a retinoid indicated for the topical
treatment of plaque psoriasis of up to 20% body
surface area involvement. (1.1)
TAZORAC Gel, 0.1% is indicated for the topical treatment of mild to
moderate facial acne vulgaris. (1.2)
Limitations of Use
The safety of TAZORAC Gel use on more than 20% body surface area has
not been established._ _(1.3)
DOSAGE AND ADMINISTRATION
Apply a thin layer of TAZORAC Gel only to the affected area once daily
in the evening. (2.1, 2.2)
Not for ophthalmic, oral, or intravaginal use. (2.2)
If contact with eyes occurs, rinse thoroughly with water. (2.2)
DOSAGE FORMS AND STRENGTHS
Gel, 0.05% and 0.1% (3)
CONTRAINDICATIONS
Pregnancy (4, 8.1)
Hypersensitivity (4)
WARNINGS AND PRECAUTIONS
Embryofetal Toxicity: TAZORAC Gel contains tazarotene, which is a
teratogen. TAZORAC Gel is contraindicated in
pregnancy. Females of child-bearing potential should have a negative
pregnancy test within 2 weeks prior to initiating
treatment and use an effective method of contraception during
treatment. (5.1)
Local Irritation: Excessive pruritus, burning, skin redness or peeling
can occur. If these reactions occur, discontinue
until the integrity of the skin has been restored, or consider
reducing dosing frequency or in the case of psoriasis,
consider switching to the lower concentration. TAZORAC Gel should not
be used on eczematous skin, as it may cause
severe irritation. (5.2)
Photosensitivity and Risk for Sunburn: Avoid exposure to sunlight,
sunlamps, and weather extremes. Wear sunscreen
daily. TAZORAC Gel should be administered with caution if the patient
is also taking drugs known to be
photosensitizers. (5.3)
ADVERSE REACTIONS
Plaque Pso